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Medtronic Model 5062
Medtronic Vascular
Summary: The Medtronic Model 5062 is an IVC filter designed to prevent pulmonary embolism. It is FDA-cleared and supported by clinical studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853398 ↗
Decision Date ?
December 4, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic Model 5062 was cleared through the FDA 510(k) pathway on December 4, 1985. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Medtronic Model 5062 is an inferior vena cava (IVC) filter used to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients who are at risk of developing embolic events.
FDA-Cleared Indications
- Use in patients at risk for pulmonary embolism when prevention of embolization is clinically indicated.
- Placement in the inferior vena cava to intercept thrombi before they reach the pulmonary arteries.
Clinical Applications
- Inferior vena cava filter placement for pulmonary embolism prevention.
- Protection from embolization in patients who cannot receive anticoagulation therapy.
- Protection from recurrent embolic events when embolization occurs despite anticoagulation, when consistent with the device labeling and treating physician assessment.
Reported off-label uses
- Temporary protection during selected high-risk procedures in patients without a standard indication for permanent IVC filtration.
- Use in selected patients with limited cardiopulmonary reserve who are considered at unusually high risk from pulmonary embolism.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes five studies, with a mix of study designs such as RCTs and retrospective analyses, spanning from 2023 to 2026. These studies provide insights into device efficacy and safety.
Reported Outcomes
Published studies report limited specific outcomes related to the Medtronic Model 5062. The evidence primarily focuses on the device's role in preventing pulmonary embolism, though detailed efficacy data is sparse.
Safety Profile
Reported complications include general risks associated with IVC filters, such as filter migration and perforation. However, specific safety data from the provided studies is not detailed.
Evidence Limitations
The evidence base for the Medtronic Model 5062 is limited, with few studies directly addressing its efficacy and safety. Further research is needed to establish comprehensive outcomes and safety profiles.
Practical Considerations
- The available FDA record identifies the device by model number and product code but does not provide complete current specifications for filter diameter, delivery system, or available sizes; verify the original labeling before use.
- Confirm compatibility between the filter, delivery system, access route, and patient anatomy before the procedure.
- Typical placement is performed through venous access, commonly the internal jugular or femoral vein, with fluoroscopic imaging and local anesthesia with or without moderate sedation.
- Review the original instructions for use for contraindications, including unsuitable IVC anatomy, active infection at the access site, or allergy to any device or procedural materials.
- Do not assume MRI safety from the FDA clearance record alone. Confirm the device's MR labeling and conditions before MRI.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Medtronic Model 5062?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Specific outcomes are limited, but the device is generally used to prevent pulmonary embolism.
What complications have been reported?
Safety data is limited, but potential complications include filter migration and perforation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.